TANTALUS Therapy in Type 2 Diabetic Patients Intolerant or Inadequately Responsive to GLP-1 Receptor Agonist Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 25
- 主要终点
- Decrees in HbA1c of at least 0.5 points and Weight loss of at least 3% of total body weight after 6 month of treatment
研究概览
简要总结
To assess the TANTALUS therapy in type 2 diabetic patients who can not tolerate GLP-1 agonist due to unacceptable side effects; and to assess the TANTALUS therapy in type 2 diabetic patients who do not sufficiently benefit from GLP-1 receptor agonist therapy
详细描述
The present protocol will address whether the effects of the TANTALUS treatment are complimentary to GLP-1 treatment which is only partially effective or whether it can replace GLP-1 treatment in individuals who cannot tolerate GLP-1 agonists because of unacceptable side effects.
This investigation will be a 3 arm multicenter study which will enroll in a Run-In Period up to 400 with type 2 diabetes mellitus. This Run-In Period will facilitate screening the patients with the aim to have a maximum of 30 patients in each arm complete the Evaluation Period of 6 months. The study aims at evaluating the TANTALUS therapy compared to GLP-1 receptor agonist therapy by evaluating improvement in glycemic control and weight after 6 months of treatment in each of the 3 study groups, which are:
- Group A: subjects on GLP-1 receptor agonist therapy only
- Group B: subjects on GLP-1 receptor agonist therapy and TANTALUS therapy
- Group C: subjects on TANTALUS therapy only
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 21 through 70 years of age
- •Type 2 diabetes duration more than 6 months and less than 10 years
- •7.8% < HbA1c < 10.5% if T2DM duration less than or equal to 5 years
- •7.8% < HbA1c < 10.0% if T2DM duration more than 5 years
- •BMI < 40 kg/m2
- •Taking at least one oral anti-diabetic medication
- •Patients treated with GLP-1 receptor agonist with at least one oral anti-diabetic medication may be included under the following conditions:
- •a. The HbA1c, before GLP-1 receptor agonist therapy was administered, was: i. 7.8% < HbA1c < 10.5% if T2DM duration less than 5 years ii. 7.8% < HbA1c < 10.0% if T2DM duration greater than 5 years b. The patient was on GLP-1 receptor agonist therapy for no more than 12 weeks
- •Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
- •If subject is taking lipid-lowering medication, the treatment must be stable for at least one month prior to enrollment
- •If subject is taking anti-hypertensive medication, the treatment must be stable for at least one month prior to enrollment
- •If subject is taking anti-depressant medication, the treatment must be stable for at least one month prior to enrollment
- •Willingness to refrain from using prescription, over the counter, or herbal weight loss products for the duration of the trial
- •Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS® System
- •Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
- •Able to provide voluntary informed consent
排除标准
- •Insulin therapy within the last 3 months
- •GLP-1 receptor agonist therapy longer than 3 months
- •Diagnosed with renal dysfunction or history of renal dysfunction
- •Taking medications known to affect gastric motility
- •Use of prescription, over the counter or herbal weight loss products or obesity drugs during the past two months
- •Experiencing severe and progressing diabetic complications (
- •Prior wound healing problems
- •Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures
- •Use of anti-psychotic medications
- •Diagnosed with eating disorder such as bulimia or binge eating
- •Obesity due to an endocrinopathy
- •Hiatal hernia requiring surgical repair or a paraesophageal hernia
- •Pregnant or lactating
- •Diagnosed with impaired liver function
- •Any prior bariatric surgery
- •Any history of pancreatitis
- •Any history of peptic ulcer disease within 5 years of enrollment
- •Diagnosed with Gastroparesis or other GI motility disorder
- •Use of active medical devices (either implantable or external) such as ICD, drug infusion device, or neurostimulator (either implanted or worn). Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
- •Cardiac history that physician feels should exclude the subject from the study.
- •Use of another investigational device or agent in the 30 days prior to enrollment
- •A history of life-threatening disease within 5 years of enrollment
- •Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
结局指标
主要结局
Decrees in HbA1c of at least 0.5 points and Weight loss of at least 3% of total body weight after 6 month of treatment
时间窗: 6 month
Change in HbA1c and weight will be assessed at baseline and 24 weeks of treatment for Group A and C. Additionally, each group will be analyzed for the weight of decrease extent, the percentage of patients achieving the endpoint, and the percentage of patients that reach an HbA1c less than 7.0%.
次要结局
- Glycemic and metabolic parameters(6 month)